Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

Summary

This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Estrogen Receptor-Positive Breast Carcinoma
• HER2-Negative Breast Carcinoma

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

National Cancer Institute (NCI)

Last updated on ClinicalTrials.gov

October 15, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

+51 more sites listed on ClinicalTrials.gov